Antenatal Dexamethasone for Late Preterm Deliveries: a Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Rate of respiratory support
研究概览
简要总结
The goal of this clinical trial is to compare dexamethasone in late preterm deliveries. The main questions it aims to answer are: Does antenatal dexamethasone reduce the need for respiratory support in late preterm infants? Does antenatal dexamethasone reduce neonatal morbidities and mortality? Does antenatal dexamethasone reduce admission to Neonatal Intensive Care Unit and length of hospital stay? Participants will be allocated into 2 groups: intervention with dexamethasone IM and control (standard care). Investigators will compare these two groups to see if antenatal dexamethasone reduces the need for respiratory support in late preterm infants, neonatal morbidities and mortality, admission to NICU and length of hospital stay.
详细描述
Study design: The study is a double-blinded randomized controlled trial, parallel group. The sequence of randomization will be generated by using an online tool (https://www.sealedenvelope.com/simple-randomiser/v1/lists) with 2 groups of treatments with ratio 1:1, block of variable size (2,4,6), list length 302, no stratification. After having a randomization sequence, the symbol of group (control or intervention) will be kept in a sealed envelope. These envelops will be also put in the order as the allocation sequence. Assessors and investigators will be blinded to the group allocation.
Participants: Participants are women with singleton pregnancy, from 18 to 45 years old, at 34+0/7 to 36+6/7 weeks of gestation and at high risk for delivery during the late preterm period in the next 7 days.
Intervention: Antenatal dexamethasone. Participants in the intervention group will be given a course of four intramuscular injections of dexamethasone 6 mg (1.2 milliliter), 12 hours apart.
Comparison: Standard care. Outcomes: Primary outcome: Need for any respiratory support in first 72 hours, which is determined when babies need to be supported with continuous positive airway pressure (CPAP), high-flow nasal cannula (HFNC), supplemental oxygen, or mechanical ventilation in first 72 hours to keep the saturation in a proper range (90-95%).
Sample size is 300 participants in 2 groups: intervention group and control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •34+0/7 to 36+6/7 weeks
- •Expected preterm delivery for any indications in the next 7 days.
排除标准
- •Fetal death
- •Severe fetal malformation
- •Twin or multiple pregnancy
- •Maternal contraindication to dexamethasone: hypersensitive with steroids, any infection
- •Severe maternal conditions such as eclampsia, cardiac arrest, antepartum hemorrhage due to placenta previa or abruption
- •Delivery estimated within 2 hours: total cervical dilation
- •Received steroids within 1 week
研究组 & 干预措施
Dexamethasone group
The intervention is antenatal dexamethasone. Participants in the intervention group will be given a course of four intramuscular injections of dexamethasone 6 mg (1.2 milliliter), 12 hours apart.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Rate of respiratory support
时间窗: First 72 hours of life
Rate of babies requiring any respiratory support such as continuous positive airway pressure (CPAP), high-flow nasal cannula (HFNC), supplemental oxygen, or mechanical ventilation in first 72 hours to keep the saturation in a proper range (90-95%).
次要结局
- Neonatal treatment outcomes(From birth to 28 days of life or death)
- Neonatal respiratory morbidities(From birth to 28 days of life or death)
- Maternal secondary outcomes(First week after delievery)
- Neonatal co-morbidities(From birth to 28 days of life or death)
- Maternal outcomes(First week after delievery)
研究者
Chau Hoang Minh Le
Principal Investigator
Chulalongkorn University